Is Transferring Evidence Across Europe a Herculean Task? Challenges of Transportability Analyses in the Context of European Union Joint Clinical Assessments

At ISPOR Europe 2025 in Glasgow, I joined Grammati Sarri (Cytel), Blythe Adamson (Flatiron Health) and Stephen Duffield (NICE) in presenting a workshop about transportability analyses, exploring hypothetical decision problems within the context of the European Union’s new Joint Clinical Assessment (JCA) process.

Grammati opened with an overview of JCAs, and how these are supposed to provide “factual” evidence summaries rather than recommendations, leaving value judgments on external validity to national HTA agencies. Through a hypothetical case study, Blythe demonstrated the challenges of selecting appropriate evidence sources when trial populations, healthcare settings, and data quality differ across member states. I emphasized challenges for the acceptability of transportability analyses based on JCA methodological guidance, which contains a shifted null hypothesis testing requirement. This requirement will disincentivize the conduct of transportability analyses, as these typically enhance external validity at the expense of precision. Stephen presented UK case studies (including NICE appraisals in NSCLC and urothelial cancer), illustrating how RWD are already being integrated into NICE appraisals, and underscored the importance of early engagement with HTA bodies.